Hepatitis B Virus Surface Antigen Prenatal, Serum
Use
The test is used for the diagnosis of acute, recent, or chronic hepatitis B. It assists in determining chronic hepatitis B status and is important for screening pregnant women for evidence of chronic hepatitis B or hepatitis B carrier state. Identifying hepatitis B in pregnant women is crucial to prevent neonatal transmission at birth.
Special Instructions
This test is specifically designed for screening or testing chronic hepatitis B in pregnant individuals. It should not be used for screening or confirmatory testing of blood donor specimens, nor is it suitable for diagnosing hepatitis B during the 'window period' of acute HBV infection. It is not intended for symptomatic individuals who may or may not have risk factors for hepatitis B virus infection. Consider alternative tests for nonpregnant or asymptomatic individuals.
Limitations
This assay is not licensed by the FDA for screening blood, plasma, and tissue donors. Results should be used in conjunction with a patient's medical history, clinical examination, and other findings. Positive HBsAg results due to recent hepatitis B vaccination may occur, and the test may not detect all infected individuals. A negative result does not exclude a possible hepatitis B infection entirely; it can occur if antigen concentration is below the detection threshold or no reaction occurs with the antibodies used in the assay. There is no established performance data for its use in newborns or with assays from other manufacturers.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 5196-1
- 5196-1
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.9 mL Serum
Minimum Volume
0.7 mL
Container
Serum gel (red-top tubes are not acceptable); Submission Container/Tube: Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions (e.g., within 2 hours for BD Vacutainer tubes) and aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, Gross lipemia, Gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 6 days |
| Frozen | 90 days |